US2024325360A1PendingUtilityA1
Therapeutic methods using vadadustat
Est. expiryJan 8, 2041(~14.5 yrs left)· nominal 20-yr term from priority
A61K 31/4412A61K 31/4418
59
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Claims
Abstract
This invention provides methods for the treatment of anemia in patients with chronic kidney disease (CKD) using vadadustat (Compound 1). Methods described herein provide alternative dosing regimens for patients having anemia. In addition, methods herein are suitable for patients converting from a previous anemia treatment including erythropoietin stimulating agent (ESA), patients who are on dialysis (e.g., peritoneal dialysis or hemodialysis), or CKD patients having certain hemoglobin (Hb) levels.
Claims
exact text as granted — not AI-modifiedWhat is claimed is:
1 . A method of treating anemia, comprising administering to a patient having anemia a dose of a compound that is {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid having the structure of Compound 1,
or a pharmaceutically acceptable salt, solvate, or hydrate thereof, wherein the dose comprises about 450 mg to about 1200 mg, or about 450 mg to about 1800 mg of Compound 1.
2 . A method of increasing hemoglobin levels in a patient having anemia, comprising administering to the patient a dose of a compound that is {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid having the structure of Compound 1,
or a pharmaceutically acceptable salt, solvate, or hydrate thereof, wherein the dose comprises about 450 mg to about 1200 mg, or about 450 mg to about 1800 mg of Compound 1, and wherein the hemoglobin levels are increased to about at least 10 g/dL from a baseline hemoglobin level.
3 . A method of maintaining hemoglobin levels in a patient having anemia, comprising administering to the patient a dose of a compound that is {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid having the structure of Compound 1,
or a pharmaceutically acceptable salt, solvate, or hydrate thereof, wherein the dose comprises about 450 mg to about 1200 mg, or about 450 mg to about 1800 mg of Compound 1, and wherein the hemoglobin levels are maintained at about 10.0 g/dL to about 13.0 g/dL.
4 . The method of any one of claims 1-3 , wherein the dose comprises about 600 mg to about 1200, or about 600 mg to about 1800 mg of Compound 1 three times weekly.
5 . The method of any one of claims 1-3 , wherein the dose comprises about 750 mg to about 1200 mg, or about 750 mg to about 1800 mg of Compound 1 once daily.
6 . The method of any one of claims 1-5 , wherein the dose is administered to the patient for at least about 12 weeks.
7 . The method of any one of claims 1-6 , wherein the dose is administered to the patient for at least about 12-260 weeks.
8 . The method of any one of claims 1-7 , wherein the patient has anemia secondary to or associated with chronic kidney disease (CKD).
9 . The method of claim 8 , wherein the CKD is dialysis-dependent CKD (DD-CKD).
10 . The method of any one of claims 1-9 , wherein the patient previously has been treated with an erythropoietin stimulating agent (ESA).
11 . The method of claim 10 , wherein the ESA is epoetin, darbepoetin alfa (DA), and/or methoxy polyethylene glycol-epoetin beta (epoetin beta pegol).
12 . A method of treating anemia, comprising administering to a patient having anemia a dose of a compound that is {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid having the structure of Compound 1,
or a pharmaceutically acceptable salt, solvate, or hydrate thereof, wherein the dose comprises about 750 mg to about 1200 mg, or about 750 mg to about 1800 mg of Compound 1 once daily.
13 . A method of increasing hemoglobin levels in a patient having anemia, comprising administering to the patient a dose of a compound that is {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid having the structure of Compound 1,
or a pharmaceutically acceptable salt, solvate, or hydrate thereof, wherein the dose comprises about 750 mg to about 1200 mg, or about 750 mg to about 1800 mg of Compound 1 once daily, and wherein the hemoglobin levels are increased to about at least 10 g/dL from a baseline hemoglobin level.
14 . A method of maintaining hemoglobin levels in a patient having anemia, comprising administering to the patient a dose of a compound that is {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid having the structure of Compound 1,
or a pharmaceutically acceptable salt, solvate, or hydrate thereof, wherein the dose comprises about 750 mg to about 1200 mg, or about 750 mg to about 1800 mg of Compound 1 once daily, and wherein the hemoglobin levels are maintained at about 10.0 g/dL to about 13.0 g/dL.
15 . The method of any one of claims 12-14 , wherein the dose comprises about 750 mg to about 900 mg of Compound 1 once daily.
16 . The method of any one of claims 12-14 , wherein the dose comprises about 750, 900, 1200, 1350, 1500, 1650, or 1800 mg of Compound 1 once daily.
17 . A method of treating anemia, comprising administering to a patient having anemia a dose of a compound that is {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid having the structure of Compound 1,
or a pharmaceutically acceptable salt, solvate, or hydrate thereof, wherein the dose comprises about 600 mg to about 1200 mg, or about 600 mg to about 1800 mg of Compound 1 three times weekly.
18 . A method of increasing hemoglobin levels in a patient having anemia, comprising administering to the patient a dose of a compound that is {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid having the structure of Compound 1,
or a pharmaceutically acceptable salt, solvate, or hydrate thereof, wherein the dose comprises about 600 mg to about 1200 mg, or about 600 mg to about 1800 mg of Compound 1 three times weekly, and wherein the hemoglobin levels are increased to about at least 10 g/dL from a baseline hemoglobin level.
19 . A method of maintaining hemoglobin levels in a patient having anemia, comprising administering to the patient a dose of a compound that is {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid having the structure of Compound 1,
or a pharmaceutically acceptable salt, solvate, or hydrate thereof, wherein the dose comprises about 600 mg to about 1200, or about 600 mg to about 1800 mg of Compound 1 three times weekly, and wherein the hemoglobin levels are maintained at about 10.0-13.0 g/dL.
20 . The method of any one of claims 17-19 , wherein the dose comprises about 600 mg to about 900 mg, or about 750 mg to about 1200 mg of Compound 1 three times weekly.
21 . The method of any one of claims 17-19 , wherein the dose comprises about 600, 750, 900, 1200, 1350, 1500, 1650, or 1800 mg of Compound 1 three times weekly.
22 . A method of treating anemia, comprising administering to a patient having anemia a dose of a compound that is {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid having the structure of Compound 1,
or a pharmaceutically acceptable salt, solvate, or hydrate thereof, wherein the dose comprises about 150 mg to about 1200 mg, or about 150 mg to about 1800 mg of the Compound 1 three times weekly, and wherein the patient was previously administered a daily dose of compound 1.
23 . A method of increasing hemoglobin levels in a patient having anemia, comprising administering to the patient a dose of a compound that is {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid having the structure of Compound 1,
or a pharmaceutically acceptable salt, solvate, or hydrate thereof, wherein the dose comprises about 150 mg to about 1200 mg, or about 150 mg to about 1800 mg of the Compound 1 three times weekly, wherein the patient was previously administered a daily dose of Compound 1, and wherein the hemoglobin levels are increased to about at least 10 g/dL from a baseline hemoglobin level.
24 . A method of maintaining hemoglobin levels in a patient having anemia, comprising administering to the patient a dose of a compound that is {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid having the structure of Compound 1,
or a pharmaceutically acceptable salt, solvate, or hydrate thereof, wherein the dose comprises about 150 mg to about 1200 mg, or about 150 mg to about 1800 mg of the Compound 1 three times weekly, wherein the patient was previously administered a daily dose of Compound 1, and wherein the hemoglobin levels are maintained at about 10.0-13.0 g/dL.
25 . The method of any one of claims 22-24 , wherein the dose comprises about 150 mg to about 600 mg, about 600 mg to about 1200 mg, or about 750 mg to about 1200 mg three times weekly.
26 . The method of any one of claims 22-24 , wherein the dose comprises about 150, 300, 450, 600, 750, 900, 1200, 1350, 1500, 1650, or 1800 mg three times weekly.
27 . The method of any one of claims 22-26 , wherein the previously-administered daily dose comprises about 150, 300, 450, or 600 mg of Compound 1.
28 . The method of any one of claims 14, 19, and 24 , wherein the hemoglobin levels are maintained at about 10.0 g/dL to about 12.0 g/dL, or the hemoglobin levels are maintained at about 11.0 g/dL to about 13.0 g/dL.
29 . The method of claim 28 , wherein the hemoglobin levels are maintained at about 11.0 g/dL to about 12.0 g/dL, or the hemoglobin levels are maintained at about 10.0 g/dL to about 11.0 g/dL.
30 . The method of any one of claims 12-29 , wherein the dose is administered to the patient for at least about 12-260 weeks.
31 . The method of claim 30 , wherein the dose is administered to the patient for at least about 12 weeks, for at least about 24 weeks, for at least about 28 weeks, for at least about 32 weeks, for at least about 36 weeks, for at least about 40 weeks, for at least about 44 weeks, for at least about 48 weeks, for at least about 52 weeks, for at least about 64 weeks, for at least about 76 weeks, for at least about 88 weeks, for at least about 104 weeks, for at least about 116 weeks, for at least about 128 weeks, for at least about 140 weeks, for at least about 156 weeks, for at least about 168 weeks, for at least about 180 weeks, for at least about 192 weeks, for at least about 208 weeks, or for at least about 260 weeks.
32 . The method of any one of claims 12-31 , wherein anemia is anemia associated with or secondary to chronic kidney disease (CKD).
33 . The method of claim 32 , wherein chronic kidney disease is dialysis-dependent chronic kidney disease (DD-CKD).
34 . A method of treating anemia, comprising administering to a patient having anemia a dose of a compound that is {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid having the structure of Compound 1,
or a pharmaceutically acceptable salt, solvate, or hydrate thereof, for at least about 12 weeks, wherein the dose comprises about 750-1200 mg, or about 750-1800 mg of Compound 1 once daily.
35 . A method of increasing hemoglobin levels in a patient having anemia, comprising administering to the patient a dose of a compound that is {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid having the structure of Compound 1,
or a pharmaceutically acceptable salt, solvate, or hydrate thereof, for at least about 12 weeks, wherein the dose comprises about 750 mg to about 1200 mg, or about 750 to about 1800 mg of Compound 1 once daily, and wherein the hemoglobin levels are increased to about at least 10 g/dL from a baseline hemoglobin level.
36 . A method of maintaining hemoglobin levels in a patient having anemia, comprising administering to the patient a dose of a compound that is {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid having the structure of Compound 1,
or a pharmaceutically acceptable salt, solvate, or hydrate thereof, for at least about 12 weeks, wherein the dose comprises about 750 mg to about 1200 mg, or about 750 to about 1800 mg of Compound 1 once daily, and wherein the hemoglobin levels are maintained at about 10.0-13.0 g/dL.
37 . The method of any one of claims 34-36 , wherein the dose comprises about 750 mg to about 900 mg of Compound 1 once daily.
38 . The method of any one of claims 34-36 , wherein the dose comprises about 750, 900, 1200, 1350, 1500, 1650, or 1800 mg of Compound 1 once daily.
39 . A method of treating anemia, comprising administering to a patient having anemia a dose of a compound that is {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid having the structure of Compound 1,
or a pharmaceutically acceptable salt, solvate, or hydrate thereof, for at least about 12 to about 260 weeks, wherein the dose comprises about 600-1200 mg, or about 600-1800 mg of Compound 1 three times weekly.
40 . A method of increasing hemoglobin levels in a patient having anemia, comprising administering to the patient a dose of a compound that is {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid having the structure of Compound 1,
or a pharmaceutically acceptable salt, solvate, or hydrate thereof, for at least about 12 weeks, wherein the dose comprises about 600 mg to about 1200 mg, or about 600 mg to about 1800 mg of Compound 1 three times weekly, and wherein the hemoglobin levels are increased to about at least 10 g/dL from a baseline hemoglobin level.
41 . A method of maintaining hemoglobin levels in a patient having anemia, comprising administering to the patient a dose of a compound that is {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid having the structure of Compound 1,
or a pharmaceutically acceptable salt, solvate, or hydrate thereof, for at least about 12 weeks, wherein the dose comprises about 600 mg to about 1200 mg, or about 600 mg to about 1800 mg of Compound 1 three times weekly, and wherein the hemoglobin levels are maintained at about 10.0-13.0 g/dL.
42 . The method of any one of claims 39-41 , wherein the dose comprises about 600 mg to about 900 mg, or about 750 mg to about 1200 mg of Compound 1 three times weekly.
43 . The method of any one of claims 39-41 , wherein the dose comprises about 600, 750, 900, 1200, 1350, 1500, 1650, or 1800 mg of Compound 1 three times weekly.
44 . A method of treating anemia, comprising administering to a patient having anemia a dose of a compound that is {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid having the structure of Compound 1,
or a pharmaceutically acceptable salt, solvate, or hydrate thereof, for at least about 12 weeks, wherein the dose comprises about 150 mg to about 1200 mg, or about 150 mg to about 1800 mg of the Compound 1 three times weekly, and wherein the patient was previously administered a daily dose of compound 1.
45 . A method of increasing hemoglobin levels in a patient having anemia, comprising administering to the patient a dose of a compound that is {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid having the structure of Compound 1,
or a pharmaceutically acceptable salt, solvate, or hydrate thereof, for at least about 12 weeks, wherein the dose comprises about 150 mg to about 1200 mg, or about 150 mg to about 1800 mg of the Compound 1 three times weekly, wherein the patient was previously administered a daily dose of Compound 1, and wherein the hemoglobin levels are increased to about at least 10 g/dL from a baseline hemoglobin level.
46 . A method of maintaining hemoglobin levels in a patient having anemia, comprising administering to the patient a dose of a compound that is {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid having the structure of Compound 1,
or a pharmaceutically acceptable salt, solvate, or hydrate thereof, for at least about 12 weeks, wherein the dose comprises about 150 mg to about 1200 mg, or about 150 mg to about 1800 mg of the Compound 1 three times weekly, wherein the patient was previously administered a daily dose of Compound 1, and wherein the hemoglobin levels are maintained at about 10.0-13.0 g/dL.
47 . The method of any one of claims 44-46 , wherein the dose comprises about 150 mg to about 600 mg, about 600 mg to about 1200 mg, or about 750 mg to about 1200 mg three times weekly.
48 . The method of any one of claims 44-46 , wherein the dose comprises about 150, 300, 450, 600, 750, 900, 1200, 1350, 1500, 1650, or 1800 mg three times weekly.
49 . The method of any one of claims 44-48 , wherein the previously-administered daily dose comprises about 150, 300, 450, or 600 mg of Compound 1.
50 . The method of any one of claims 36, 41 and 46 , wherein the hemoglobin levels are maintained at about 10.0 g/dL to about 12.0 g/dL, or the hemoglobin levels are maintained at about 11.0 g/dL to about 13.0 g/dL.
51 . The method of claim 50 , wherein the hemoglobin levels are maintained at about 11.0 g/dL to about 12.0 g/dL, or the hemoglobin levels are maintained at about 10.0 g/dL to about 11.0 g/dL.
52 . The method of any one of claims 34-51 , wherein the dose is administered to the patient for at least about 12 weeks, for at least about 24 weeks, for at least about 28 weeks, for at least about 32 weeks, for at least about 36 weeks, for at least about 40 weeks, for at least about 44 weeks, for at least about 48 weeks, for at least about 52 weeks, for at least about 64 weeks, for at least about 76 weeks, for at least about 88 weeks, for at least about 104 weeks, for at least about 116 weeks, for at least about 128 weeks, for at least about 140 weeks, for at least about 156 weeks, for at least about 168 weeks, for at least about 180 weeks, for at least about 192 weeks, for at least about 208 weeks, or for at least about 260 weeks.
53 . The method of any one of claims 34-52 , wherein anemia is anemia associated with or secondary to chronic kidney disease (CKD).
54 . The method of claim 53 , wherein chronic kidney disease is dialysis-dependent chronic kidney disease (DD-CKD).
55 . A method of treating anemia, comprising administering to a patient having anemia a dose of a compound that is {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid having the structure of Compound 1,
or a pharmaceutically acceptable salt, solvate, or hydrate thereof, wherein the dose comprises about 750-1200 mg, or about 750-1800 mg of Compound 1 once daily, and wherein the patient was previously treated with an erythropoietin stimulating agent (ESA).
56 . A method of increasing hemoglobin levels in a patient having anemia, comprising administering to the patient a dose of a compound that is {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid having the structure of Compound 1,
or a pharmaceutically acceptable salt, solvate, or hydrate thereof, wherein the dose comprises about 750 mg to about 1200 mg, or about 750 mg to about 1800 mg of Compound 1 once daily, and wherein the patient was previously treated with an erythropoietin stimulating agent (ESA), and wherein the hemoglobin levels are increased to about at least 10 g/dL from a baseline hemoglobin level.
57 . A method of maintaining hemoglobin levels in a patient having anemia, comprising administering to the patient a dose of a compound that is {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid having the structure of Compound 1,
or a pharmaceutically acceptable salt, solvate, or hydrate thereof, wherein the dose comprises about 750 mg to about 1200 mg, or about 750 mg to about 1800 mg of Compound 1 once daily, wherein the patient was previously treated with an erythropoietin stimulating agent (ESA), and wherein the hemoglobin levels are maintained at about 10.0-13.0 g/dL.
58 . The method of any one of claims 55-57 , wherein the dose comprises about 750 mg to about 900 mg of Compound 1 once daily.
59 . The method of any one of claims 55-57 , wherein the dose comprises about 750, 900, 1200, 1350, 1500, 1650, or 1800 mg of Compound 1 once daily.
60 . A method of treating anemia, comprising administering to a patient having anemia a dose of a compound that is {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid having the structure of Compound 1,
or a pharmaceutically acceptable salt, solvate, or hydrate thereof, wherein the dose comprises about 600-1200 mg, or about 600-1800 mg of Compound 1 three times weekly, and wherein the patient was previously treated with an erythropoietin stimulating agent (ESA).
61 . A method of increasing hemoglobin levels in a patient having anemia, comprising administering to the patient a dose of a compound that is {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid having the structure of Compound 1,
or a pharmaceutically acceptable salt, solvate, or hydrate thereof, wherein the dose comprises about 600 mg to about 1200 mg, or about 600 mg to about 1800 mg of Compound 1 three times weekly, wherein the patient was previously treated with an erythropoietin stimulating agent (ESA), and wherein the hemoglobin levels are increased to about at least 10 g/dL from a baseline hemoglobin level.
62 . A method of maintaining hemoglobin levels in a patient having anemia, comprising administering to the patient a dose of a compound that is {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid having the structure of Compound 1,
or a pharmaceutically acceptable salt, solvate, or hydrate thereof, wherein the dose comprises about 600 mg to about 1200 mg, or about 600 mg to about 1800 mg of Compound 1 three times weekly, wherein the patient was previously treated with an erythropoietin stimulating agent (ESA), and wherein the hemoglobin levels are maintained at about 10.0-13.0 g/dL.
63 . The method of any one of claims 60-62 , wherein the dose comprises about 600 mg to about 900 mg, or about 750 mg to about 1200 mg of Compound 1 three times weekly.
64 . The method of any one of claims 60-62 , wherein the dose comprises about 600, 750, 900, 1200, 1350, 1500, 1650, or 1800 mg of Compound 1 three times weekly.
65 . A method of treating anemia, comprising administering to a patient having anemia a dose of a compound that is {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid having the structure of Compound 1,
or a pharmaceutically acceptable salt, solvate, or hydrate thereof, wherein the dose comprises about 150 mg to about 1200 mg, or about 150 mg to about 1800 mg of the Compound 1 three times weekly, wherein the patient was previously administered a daily dose of Compound 1, and wherein the patient was previously treated with an erythropoietin stimulating agent (ESA).
66 . A method of increasing hemoglobin levels in a patient having anemia, comprising administering to the patient a dose of a compound that is {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid having the structure of Compound 1,
or a pharmaceutically acceptable salt, solvate, or hydrate thereof, wherein the dose comprises about 150 mg to about 1200 mg, or about 150 mg to about 1800 mg of the Compound 1 three times weekly, wherein the patient was previously administered a daily dose of Compound 1, wherein the patient was previously treated with an erythropoietin stimulating agent (ESA), and wherein the hemoglobin levels are increased to about at least 10 g/dL from a baseline hemoglobin level.
67 . A method of maintaining hemoglobin levels in a patient having anemia, comprising administering to the patient a dose of a compound that is {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid having the structure of Compound 1,
or a pharmaceutically acceptable salt, solvate, or hydrate thereof, wherein the dose comprises about 150-1200 mg, or about 150-1800 mg of the Compound 1 three times weekly, wherein the patient was previously administered a daily dose of Compound 1, wherein the patient was previously treated with an erythropoietin stimulating agent (ESA), and wherein the hemoglobin levels are maintained at about 10.0-13.0 g/dL.
68 . The method of any one of claims 65-67 , wherein the dose comprises about 150 mg to about 600 mg, about 600 mg to about 1200 mg, or about 750 mg to about 1200 mg three times weekly.
69 . The method of any one of claims 65-67 , wherein the dose comprises about 150, 300, 450, 600, 750, 900, 1200, 1350, 1500, 1650, or 1800 mg three times weekly.
70 . The method of any one of claims 65-69 , wherein the patient was previously administered a daily dose comprises about 150, 300, 450, or 600 mg of Compound 1.
71 . The method of claim any one of claims 57, 62, and 67 , wherein the hemoglobin levels are maintained at about 10.0 g/dL to about 12.0 g/dL, or the hemoglobin levels are maintained at about 11.0 g/dL to about 13.0 g/dL.
72 . The method of claim 71 , wherein the hemoglobin levels are maintained at about 11.0 g/dL to about 12.0 g/dL, or the hemoglobin levels are maintained at about 10.0 g/dL to about 11.0 g/dL.
73 . The method of any one of claims 55-72 , wherein the dose is administered to the patient for at least about 12-260 weeks.
74 . The method of claim 73 , wherein the dose is administered to the patient for at least about 12 weeks, for at least about 24 weeks, for at least about 28 weeks, for at least about 32 weeks, for at least about 36 weeks, for at least about 40 weeks, for at least about 44 weeks, for at least about 48 weeks, for at least about 52 weeks, for at least about 64 weeks, for at least about 76 weeks, for at least about 88 weeks, for at least about 104 weeks, for at least about 116 weeks, for at least about 128 weeks, for at least about 140 weeks, for at least about 156 weeks, for at least about 168 weeks, for at least about 180 weeks, for at least about 192 weeks, for at least about 208 weeks, or for at least about 260 weeks.
75 . The method of any one of claims 55-74 , wherein anemia is anemia associated with or secondary to chronic kidney disease (CKD).
76 . The method of claim 75 , wherein chronic kidney disease is dialysis-dependent chronic kidney disease (DD-CKD).
77 . A method of treating anemia, comprising administering to a patient having anemia a dose of a compound that is {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid having the structure of Compound 1,
or a pharmaceutically acceptable salt, solvate, or hydrate thereof, wherein the dose comprises about 750-1200 mg, or about 750-1800 mg of Compound 1 once daily, and wherein anemia is anemia associated with or secondary to dialysis-dependent chronic kidney disease (DD-CKD).
78 . A method of increasing hemoglobin levels in a patient having anemia, comprising administering to the patient a dose of a compound that is {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid having the structure of Compound 1,
or a pharmaceutically acceptable salt, solvate, or hydrate thereof, wherein the dose comprises about 750 mg to about 1200 mg, or about 750 mg to about 1800 mg of Compound 1 once daily, wherein anemia is anemia associated with or secondary to dialysis-dependent chronic kidney disease (DD-CKD), and wherein the hemoglobin levels are increased to about at least 10 g/dL from a baseline hemoglobin level.
79 . A method of maintaining hemoglobin levels in a patient having anemia, comprising administering to the patient a dose of a compound that is {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid having the structure of Compound 1,
or a pharmaceutically acceptable salt, solvate, or hydrate thereof, wherein dose, comprises about 750 mg to about 1200 mg, or about 750 mg to about 1800 mg of Compound 1 once daily, wherein anemia is anemia associated with or secondary to dialysis-dependent chronic kidney disease (DD-CKD), and wherein the hemoglobin levels are maintained at about 10.0-13.0 g/dL.
80 . The method of any one of claims 77-79 , wherein the dose comprises about 750 mg to about 900 mg of Compound 1 once daily.
81 . The method of any one of claims 77-79 , wherein the dose comprises about 750, 900, 1200, 1350, 1500, 1650, or 1800 mg of Compound 1 once daily.
82 . A method of treating anemia, comprising administering to a patient having anemia a dose of a compound that is {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid having the structure of Compound 1,
or a pharmaceutically acceptable salt, solvate, or hydrate thereof, wherein the dose comprises about 600-1200 mg, or about 600-1800 mg of Compound 1 three times weekly, and wherein anemia is anemia associated with or secondary to dialysis-dependent chronic kidney disease (DD-CKD).
83 . A method of increasing hemoglobin levels in a patient having anemia, comprising administering to the patient a dose of a compound that is {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid having the structure of Compound 1,
or a pharmaceutically acceptable salt, solvate, or hydrate thereof, wherein the dose comprises about 600 mg to about 1200 mg, or about 600 mg to about 1800 mg of Compound 1 three times weekly, wherein anemia is anemia associated with or secondary to dialysis-dependent chronic kidney disease (DD-CKD), and wherein the hemoglobin levels are increased to about at least 10 g/dL from a baseline hemoglobin level.
84 . A method of maintaining hemoglobin levels in a patient having anemia, comprising administering to the patient a dose of a compound that is {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid having the structure of Compound 1,
or a pharmaceutically acceptable salt, solvate, or hydrate thereof, wherein the dose comprises about 600 mg to about 1200 mg, or about 600 mg to about 1800 mg of Compound 1 three times weekly, wherein anemia is anemia associated with or secondary to dialysis-dependent chronic kidney disease (DD-CKD), and wherein the hemoglobin levels are maintained at about 10.0-13.0 g/dL.
85 . The method of any one of claims 82-84 , wherein the dose comprises about 600 mg to about 900 mg, or about 750 mg to about 1200 mg of Compound 1 three times weekly.
86 . The method of any one of claims 82-84 , wherein the dose comprises about 600, 750, 900, 1200, 1350, 1500, 1650, or 1800 mg of Compound 1 three times weekly.
87 . A method of treating anemia, comprising administering to a patient having anemia a dose of a compound that is {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid having the structure of Compound 1,
or a pharmaceutically acceptable salt, solvate, or hydrate thereof, wherein the dose comprises about 150 mg to about 1200 mg, or about 150 mg to about 1800 mg of the Compound 1 three times weekly, wherein the patient was previously administered a daily dose of Compound 1, and wherein anemia is anemia associated with or secondary to dialysis-dependent chronic kidney disease (DD-CKD).
88 . A method of increasing hemoglobin levels in a patient having anemia, comprising administering to the patient a dose of a compound that is {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid having the structure of Compound 1,
or a pharmaceutically acceptable salt, solvate, or hydrate thereof, wherein the dose comprises about 150 mg to about 1200 mg, or about 150 mg to about 1800 mg of the Compound 1 three times weekly, wherein the patient was previously administered a daily dose of Compound 1, wherein anemia is anemia associated with or secondary to dialysis-dependent chronic kidney disease (DD-CKD), and wherein the hemoglobin levels are increased to about at least 10 g/dL from a baseline hemoglobin level.
89 . A method of maintaining hemoglobin levels in a patient having anemia, comprising administering to the patient a dose of a compound that is {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid having the structure of Compound 1,
or a pharmaceutically acceptable salt, solvate, or hydrate thereof, wherein the dose comprises about 150 mg to about 1200 mg, or about 150 mg to about 1800 mg of the Compound 1 three times weekly, wherein the patient was previously administered a daily dose of Compound 1, wherein anemia is anemia associated with or secondary to dialysis-dependent chronic kidney disease (DD-CKD), and wherein the hemoglobin levels are maintained at about 10.0-13.0 g/dL.
90 . The method of any one of claims 87-89 , wherein the dose comprises about 150 mg to about 600 mg, about 600 mg to about 1200 mg, or about 750 mg to about 1200 mg three times weekly.
91 . The method of any one of claims 87-89 , wherein the dose comprises about 150, 300, 450, 600, 750, 900, 1200, 1350, 1500, 1650, or 1800 mg three times weekly.
92 . The method of any one of claims 87-91 , wherein the previously-administered daily dose comprises about 150, 300, 450, or 600 mg of Compound 1.
93 . The method of any one of claims 79, 84, and 89 , wherein the hemoglobin levels are maintained at about 10.0 g/dL to about 12.0 g/dL, or the hemoglobin levels are maintained at about 11.0 g/dL to about 13.0 g/dL.
94 . The method of claim 93 , wherein the hemoglobin levels are maintained at about 11.0 g/dL to about 12.0 g/dL, or the hemoglobin levels are maintained at about 10.0 g/dL to about 11.0 g/dL.
95 . The method of any one of claims 77-94 , wherein the dose is administered to the patient for at least about 12-260 weeks.
96 . The method of claim 95 , wherein the dose is administered to the patient for at least about 12 weeks, for at least about 24 weeks, for at least about 28 weeks, for at least about 32 weeks, for at least about 36 weeks, for at least about 40 weeks, for at least about 44 weeks, for at least about 48 weeks, for at least about 52 weeks, for at least about 64 weeks, for at least about 76 weeks, for at least about 88 weeks, for at least about 104 weeks, for at least about 116 weeks, for at least about 128 weeks, for at least about 140 weeks, for at least about 156 weeks, for at least about 168 weeks, for at least about 180 weeks, for at least about 192 weeks, for at least about 208 weeks, or for at least about 260 weeks.
97 . A method of treating anemia, comprising administering to a patient having anemia a dose of a compound that is {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid having the structure of Compound 1,
or a pharmaceutically acceptable salt, solvate, or hydrate thereof, wherein the dose comprises about 750-1200 mg, or about 750-1800 mg of Compound 1 once daily, wherein the patient was previously treated with an erythropoietin stimulating agent (ESA), and wherein anemia is anemia associated with or secondary to dialysis-dependent chronic kidney disease (DD-CKD).
98 . A method of increasing hemoglobin levels in a patient having anemia, comprising administering to the patient a dose of a compound that is {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid having the structure of Compound 1,
or a pharmaceutically acceptable salt, solvate, or hydrate thereof, wherein the dose comprises about 750 mg to about 1200 mg, or about 750 mg to about 1800 mg of Compound 1 once daily, wherein the patient was previously treated with an erythropoietin stimulating agent (ESA), wherein anemia is anemia associated with or secondary to dialysis-dependent chronic kidney disease (DD-CKD), and wherein the hemoglobin levels are increased to about at least 10 g/dL from a baseline hemoglobin level.
99 . A method of maintaining hemoglobin levels in a patient having anemia, comprising administering to the patient a dose of a compound that is {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid having the structure of Compound 1,
or a pharmaceutically acceptable salt, solvate, or hydrate thereof, wherein the dose comprises about 750 mg to about 1200 mg, or about 750 mg to about 1800 mg of Compound 1 once daily, wherein the patient was previously treated with an erythropoietin stimulating agent (ESA), wherein anemia is anemia associated with or secondary to dialysis-dependent chronic kidney disease (DD-CKD), and wherein the hemoglobin levels are maintained at about 10.0-13.0 g/dL.
100 . The method of any one of claims 97-99 , wherein the dose comprises about 750 mg to about 900 mg of Compound 1 once daily.
101 . The method of any one of claims 97-99 , wherein the dose comprises about 750, 900, 1200, 1350, 1500, 1650, or 1800 mg of Compound 1 once daily.
102 . A method of treating anemia, comprising administering to a patient having anemia a dose of a compound that is {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid having the structure of Compound 1,
or a pharmaceutically acceptable salt, solvate, or hydrate thereof, wherein the dose comprises about 600-1200 mg, or about 600-1800 mg of Compound 1 three times weekly, wherein the patient was previously treated with an erythropoietin stimulating agent (ESA), and wherein anemia is anemia associated with or secondary to dialysis-dependent chronic kidney disease (DD-CKD).
103 . A method of increasing hemoglobin levels in a patient having anemia, comprising administering to the patient a dose of a compound that is {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid having the structure of Compound 1,
or a pharmaceutically acceptable salt, solvate, or hydrate thereof, wherein the dose comprises about 600 mg to about 1200 mg, or about 600 mg to about 1800 mg of Compound 1 three times weekly, wherein the patient was previously treated with an erythropoietin stimulating agent (ESA), wherein anemia is anemia associated with or secondary to dialysis-dependent chronic kidney disease (DD-CKD), and wherein the hemoglobin levels are increased to about at least 10 g/dL from a baseline hemoglobin level.
104 . A method of maintaining hemoglobin levels in a patient having anemia, comprising administering to the patient a dose of a compound that is {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid having the structure of Compound 1,
or a pharmaceutically acceptable salt, solvate, or hydrate thereof, wherein the dose comprises about 600 mg to about 1200 mg, or about 600 mg to about 1800 mg of Compound 1 three times weekly, wherein the patient was previously treated with an erythropoietin stimulating agent (ESA), wherein anemia is anemia associated with or secondary to dialysis-dependent chronic kidney disease (DD-CKD), and wherein the hemoglobin levels are maintained at about 10.0-13.0 g/dL.
105 . The method of any one of claims 102-104 , wherein the dose comprises about 600 mg to about 900 mg, or about 750 mg to about 1200 mg of Compound 1 three times weekly.
106 . The method of any one of claims 102-104 , wherein the dose comprises about 600, 750, 900, 1200, 1350, 1500, 1650, or 1800 mg of Compound 1 three times weekly.
107 . A method for treating anemia, comprising administering to a patient having anemia a dose of a compound that is {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid having the structure of Compound 1,
or a pharmaceutically acceptable salt, solvate, or hydrate thereof, wherein the dose comprises about 150 mg to about 1200 mg, or about 150 mg to about 1800 mg of the Compound 1 three times weekly, wherein the patient was previously administered a daily dose of Compound 1, wherein the patient was previously treated with an erythropoietin stimulating agent (ESA), and wherein anemia is anemia associated with or secondary to dialysis-dependent chronic kidney disease (DD-CKD).
108 . A method of increasing hemoglobin levels in a patient having anemia, comprising administering to the patient a dose of a compound that is {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid having the structure of Compound 1,
or a pharmaceutically acceptable salt, solvate, or hydrate thereof, wherein the dose comprises about 150-1200 mg, or about 150-1800 mg of the Compound 1 three times weekly, wherein the patient was previously administered a daily dose of Compound 1, wherein the patient was previously treated with an erythropoietin stimulating agent (ESA), wherein anemia is anemia associated with or secondary to dialysis-dependent chronic kidney disease (DD-CKD), and wherein the hemoglobin levels are increased to about at least 10 g/dL from a baseline hemoglobin level.
109 . A method of maintaining hemoglobin levels in a patient having anemia, comprising administering to the patient a dose of a compound that is {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid having the structure of Compound 1,
or a pharmaceutically acceptable salt, solvate, or hydrate thereof, wherein the dose comprises about 150 mg to about 1200 mg, or about 150 mg to about 1800 mg of the Compound 1 three times weekly, wherein the patient was previously administered a daily dose of Compound 1, wherein the patient was previously treated with an erythropoietin stimulating agent (ESA), wherein anemia is anemia associated with or secondary to dialysis-dependent chronic kidney disease (DD-CKD), and wherein the hemoglobin levels are maintained at about 10.0-13.0 g/dL.
110 . The method of any one of claims 107-109 , wherein the dose comprises about 150 mg to about 600 mg, about 600 mg to about 1200 mg, or about 750 mg to about 1200 mg three times weekly.
111 . The method of any one of claims 107-109 , wherein the dose comprises about 150, 300, 450, 600, 750, 900, 1200, 1350, 1500, 1650, or 1800 mg three times weekly.
112 . The method of any one of claims 107-111 , wherein the previously-administered daily dose comprises about 150, 300, 450, or 600 mg of Compound 1.
113 . The method of any one of claims 99, 104, and 109 , wherein the hemoglobin levels are maintained at about 10.0 g/dL to about 12.0 g/dL, or wherein the hemoglobin levels are maintained at about 11.0 g/dL to about 13.0 g/dL.
114 . The method of claim 113 , wherein the hemoglobin levels are maintained at about 11.0 g/dL to about 12.0 g/dL, or the hemoglobin levels are maintained at about 10.0 g/dL to about 11.0 g/dL.
115 . The method of any one of claims 97-114 , wherein the dose is administered to the patient for at least about 12-260 weeks.
116 . The method of claim 115 , wherein the dose is administered to the patient for at least about 12 weeks, for at least about 24 weeks, for at least about 28 weeks, for at least about 32 weeks, for at least about 36 weeks, for at least about 40 weeks, for at least about 44 weeks, for at least about 48 weeks, for at least about 52 weeks, for at least about 64 weeks, for at least about 76 weeks, for at least about 88 weeks, for at least about 104 weeks, for at least about 116 weeks, for at least about 128 weeks, for at least about 140 weeks, for at least about 156 weeks, for at least about 168 weeks, for at least about 180 weeks, for at least about 192 weeks, for at least about 208 weeks, or for at least about 260 weeks.
117 . A method of treating anemia, comprising administering to a patient having anemia a starting dose of a compound that is {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid having the structure of Compound 1,
or a pharmaceutically acceptable salt, solvate, or hydrate thereof, wherein the starting dose comprises about 750 mg to about 1200 mg or about 750 mg to about 1800 mg of Compound 1 once daily, or about 600 mg to about 1200 mg or about 600 mg to about 1800 mg of Compound 1 three times weekly; and
adjusting the dose by about 150 mg to about 300 mg of Compound 1 if the patient has a hemoglobin level of <10.0 g/dL or >11.0 g/dL following administration of the starting dose.
118 . The method of claim 117 , wherein adjusting comprises adjusting the dose by about 150 mg of Compound 1 if the patient has a hemoglobin level of <10.0 g/dL or >11.0 g/dL following administration of the starting dose.
119 . The method of claim 117 , wherein adjusting comprises adjusting the dose by about 300 mg of Compound 1 if the patient has a hemoglobin level of <10.0 g/dL or >11.0 g/dL following administration of the starting dose.
120 . The method of claim 117 , wherein adjusting comprises increasing the dose by about 150 mg of Compound 1 if the patient has a hemoglobin level of <10.0 g/dL following administration of the starting dose.
121 . The method of claim 117 , wherein adjusting comprises increasing the dose by about 300 mg of Compound 1 if the patient has a hemoglobin level of <10.0 g/dL following administration of the starting dose.
122 . The method of claim 117 , wherein adjusting comprises decreasing the dose by about 150 mg of Compound 1 if the patient has a hemoglobin level of >11.0 g/dL following administration of the starting dose.
123 . The method of claim 117 , wherein adjusting comprises decreasing the dose by about 300 mg of Compound 1 if the patient has a hemoglobin level of >1.0 g/dL following administration of the starting dose.
124 . A method of treating anemia, comprising administering to a patient having anemia a starting dose of a compound that is {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid having the structure of Compound 1,
or a pharmaceutically acceptable salt, solvate, or hydrate thereof, wherein the starting dose comprises about 750 mg to about 1200 mg or about 750 mg to about 1800 mg of Compound 1 once daily, or about 600-1200 mg or about 600-1800 mg three times weekly; and
decreasing the starting dose by 150-300 mg of Compound 1 if the patient's hemoglobin level increases by >1.0 g/dL within a 2-week period.
125 . The method of claim 124 , further comprises decreasing the dose by about 150 mg of Compound 1 if the patient's hemoglobin level increases by >1.0 g/dL within a 2-week period.
126 . The method of claim 124 , further comprises decreasing the dose by about 300 mg of Compound 1 if the patient's hemoglobin level increases by >1.0 g/dL within a 2-week period.
127 . The method of any one of claims 117-126 , wherein the starting dose comprises about 750 mg to about 1200 mg of Compound 1 once daily.
128 . The method of claim 127 , wherein the starting dose comprises about 750 mg or about 900 mg of Compound 1 once daily.
129 . The method of any one of claims 117-126 , wherein the starting dose comprises about 600 mg to about 1200 mg of Compound 1 three times weekly.
130 . The method of claim 129 , wherein the starting dose comprises about 600, 750, or 900 mg of Compound 1 three times weekly.
131 . The method of any one of claims 117-130 , wherein the starting dose is administered to the patient for about ≥4 weeks.
132 . The method of any one of claims 117-131 , wherein anemia is anemia associated with or secondary to chronic kidney disease (CKD).
133 . The method of claim 132 , wherein chronic kidney disease is dialysis-dependent chronic kidney disease (DD-CKD).
134 . The method of any one of claims 12-133 , wherein the patient previously has been treated with an erythropoiesis stimulating agent (ESA).
135 . The method of claim 134 , wherein the ESA is epoetin, darbepoetin alfa (DA), or methoxy polyethylene glycol-epoetin beta (epoetin beta pegol).
136 . The method of claim 135 , wherein the epoetin is epoetin alfa.
137 . The method of claim 136 , wherein the patient previously has been treated with epoetin alfa at a dose of about 10 U/kg of body weight to about 500 U/kg of body weight three times weekly.
138 . The method of claim 137 , wherein the patient previously has been treated with epoetin alfa at a dose of about 25 U/kg of body weight to about 300 U/kg of body weight three times weekly.
139 . The method of claim 137 or 138 , wherein the patient previously has been treated with epoetin alfa at a dose of about 50 U/kg of body weight to 200 U/kg of body weight three times weekly.
140 . The method of claim 136 , wherein the patient previously has been treated with about ≤90 U/kg/week epoetin alfa.
141 . The method of claim 136 , wherein the patient previously has been treated with about >90 U/kg/week to about <300 U/kg/week epoetin alfa, or wherein the patient previously has been treated with about ≥300 U/kg/week epoetin alfa, or wherein the patient previously has been treated with epoetin alfa at an amount of about 1,500 U/week to about 90,000 U/week.
142 . The method of claim 136 , wherein the patient previously has been treated with epoetin alfa at an amount of about 4,500 U/week.
143 . The method of claim 135 , wherein the ESA is darbepoetin alfa.
144 . The method of claim 143 , wherein the patient previously has been treated with DA at a dose of about 0.25 μg/kg of body weight to 0.75 μg/kg of body weight once weekly or once every two weeks.
145 . The method of claim 144 , wherein the patient previously has been treated with DA at a dose of about 0.45 μg/kg of body weight once weekly.
146 . The method of claim 144 , wherein the patient previously has been treated with DA at a dose of about 0.75 μg/kg of body weight once every two weeks.
147 . The method of claim 143 , wherein the patient previously has been treated with DA at an amount of about 6.25-200 μg/week.
148 . The method of claim 143 , wherein the patient previously has been treated with ≤0.45 μg/kg/week DA, or wherein the patient previously has been treated with >0.45 μg/kg/week and ≤1.5 μg/kg/week DA.
149 . The method of claim 135 , wherein the ESA is epoetin beta pegol.
150 . The method of claim 149 , wherein the patient previously has been treated with epoetin beta pegol at a dose of about 0.3 μg/kg of body weight to about 1.2 μg/kg of body weight once every two weeks or about 0.6 μg/kg of body weight to about 2.4 μg/kg of body weight once a month.
151 . The method of claim 150 , wherein the patient previously has been treated with epoetin beta pegol at a dose of about 0.6 μg/kg of body weight once every two weeks or about 1.2 μg/kg of body weight once a month.
152 . The method of claim 149 , wherein the patient previously has been treated with ≤250 μg/month epoetin beta pegol.
153 . The method of any one of claims 134-152 , wherein the patient previously has been treated with an ESA for about ≥4 weeks.
154 . A method of treating anemia, comprising administering to a patient having anemia a dose of a compound that is {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid having the structure of Compound 1,
or a pharmaceutically acceptable salt, solvate, or hydrate thereof, wherein the dose comprises about 750 mg of Compound 1 once daily, wherein the patient was previously treated with an erythropoietin stimulating agent (ESA), and wherein anemia is anemia associated with or secondary to dialysis-dependent chronic kidney disease (DD-CKD).
155 . A method of increasing hemoglobin levels in a patient having anemia, comprising administering to the patient a dose of a compound that is {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid having the structure of Compound 1,
or a pharmaceutically acceptable salt, solvate, or hydrate thereof, wherein the dose comprises about 750 mg of Compound 1 once daily, wherein the patient was previously treated with an erythropoietin stimulating agent (ESA), wherein anemia is anemia associated with or secondary to dialysis-dependent chronic kidney disease (DD-CKD), and wherein the hemoglobin levels are increased to about at least 10 g/dL from a baseline hemoglobin level.
156 . A method of maintaining hemoglobin levels in a patient having anemia, comprising administering to the patient a dose of a compound that is {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid having the structure of Compound 1,
or a pharmaceutically acceptable salt, solvate, or hydrate thereof, wherein the dose comprises about 750 mg of Compound 1 once daily, wherein the patient was previously treated with an erythropoietin stimulating agent (ESA), wherein anemia is anemia associated with or secondary to dialysis-dependent chronic kidney disease (DD-CKD), and wherein the hemoglobin levels maintained at about 10.0-13.0 g/dL.
157 . A method of treating anemia, comprising administering to a patient having anemia a dose of a compound that is {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid having the structure of Compound 1,
or a pharmaceutically acceptable salt, solvate, or hydrate thereof, wherein the dose comprises about 900 mg of Compound 1 once daily, wherein the patient was previously treated with an erythropoietin stimulating agent (ESA), wherein anemia is anemia associated with or secondary to dialysis-dependent chronic kidney disease (DD-CKD).
158 . A method of increasing hemoglobin levels in a patient having anemia, comprising administering to the patient a dose of a compound that is {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid having the structure of Compound 1,
or a pharmaceutically acceptable salt, solvate, or hydrate thereof, wherein the dose comprises about 900 mg of Compound 1 once daily, wherein the patient was previously treated with an erythropoietin stimulating agent (ESA), wherein anemia is anemia associated with or secondary to dialysis-dependent chronic kidney disease (DD-CKD), and wherein the hemoglobin levels are increased to about at least 10 g/dL from a baseline hemoglobin level.
159 . A method of maintaining hemoglobin levels in a patient having anemia, comprising administering to the patient a dose of a compound that is {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid having the structure of Compound 1,
or a pharmaceutically acceptable salt, solvate, or hydrate thereof, wherein the dose comprises about 900 mg of Compound 1 once daily, wherein the patient was previously treated with an erythropoietin stimulating agent (ESA), wherein anemia is anemia associated with or secondary to dialysis-dependent chronic kidney disease (DD-CKD), and wherein the hemoglobin levels maintained at about 10.0-13.0 g/dL.
160 . A method of treating anemia, comprising administering to a patient having anemia a dose of a compound that is {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid having the structure of Compound 1,
or a pharmaceutically acceptable salt, solvate, or hydrate thereof, wherein the dose comprises about 600 mg of Compound 1 three times weekly, wherein the patient was previously treated with an erythropoietin stimulating agent (ESA), wherein anemia is anemia associated with or secondary to dialysis-dependent chronic kidney disease (DD-CKD).
161 . A method of increasing hemoglobin levels in a patient having anemia, comprising administering to the patient a dose of a compound that is {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid having the structure of Compound 1,
or a pharmaceutically acceptable salt, solvate, or hydrate thereof, wherein the dose comprises about 600 mg of Compound 1 three times weekly, wherein the patient was previously treated with an erythropoietin stimulating agent (ESA), wherein anemia is anemia associated with or secondary to dialysis-dependent chronic kidney disease (DD-CKD), and wherein the hemoglobin levels are increased to about at least 10 g/dL from a baseline hemoglobin level.
162 . A method of maintaining hemoglobin levels in a patient having anemia, comprising administering to the patient a dose of a compound that is {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid having the structure of Compound 1,
or a pharmaceutically acceptable salt, solvate, or hydrate thereof, wherein the dose comprises about 600 mg of Compound 1 three times weekly, wherein the patient was previously treated with an erythropoietin stimulating agent (ESA), wherein anemia is anemia associated with or secondary to dialysis-dependent chronic kidney disease (DD-CKD), and wherein the hemoglobin levels maintained at about 10.0-13.0 g/dL.
163 . A method of treating anemia, comprising administering to a patient having anemia a dose of a compound that is {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid having the structure of Compound 1,
or a pharmaceutically acceptable salt, solvate, or hydrate thereof, wherein the dose comprises about 750 mg of Compound 1 three times weekly, wherein the patient was previously treated with an erythropoietin stimulating agent (ESA), wherein anemia is anemia associated with or secondary to dialysis-dependent chronic kidney disease (DD-CKD).
164 . A method of increasing hemoglobin levels in a patient having anemia, comprising administering to the patient a dose of a compound that is {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid having the structure of Compound 1,
or a pharmaceutically acceptable salt, solvate, or hydrate thereof, wherein the dose comprises about 750 mg of Compound 1 three times weekly, wherein the patient was previously treated with an erythropoietin stimulating agent (ESA), wherein anemia is anemia associated with or secondary to dialysis-dependent chronic kidney disease (DD-CKD), and wherein the hemoglobin levels are increased to about at least 10 g/dL from a baseline hemoglobin level.
165 . A method of maintaining hemoglobin levels in a patient having anemia, comprising administering to the patient a dose of a compound that is {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid having the structure of Compound 1,
or a pharmaceutically acceptable salt, solvate, or hydrate thereof, wherein the dose comprises about 750 mg of Compound 1 three times weekly, wherein the patient was previously treated with an erythropoietin stimulating agent (ESA), wherein anemia is anemia associated with or secondary to dialysis-dependent chronic kidney disease (DD-CKD), and wherein the hemoglobin levels maintained at about 10.0-13.0 g/dL.
166 . A method of treating anemia, comprising administering to a patient having anemia a dose of a compound that is {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid having the structure of Compound 1,
or a pharmaceutically acceptable salt, solvate, or hydrate thereof, wherein the dose comprises about 900 mg of Compound 1 three times weekly, wherein the patient was previously treated with an erythropoietin stimulating agent (ESA), wherein anemia is anemia associated with or secondary to dialysis-dependent chronic kidney disease (DD-CKD).
167 . A method of increasing hemoglobin levels in a patient having anemia, comprising administering to the patient a dose of a compound that is {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid having the structure of Compound 1,
or a pharmaceutically acceptable salt, solvate, or hydrate thereof, wherein the dose comprises about 900 mg of Compound 1 three times weekly, wherein the patient was previously treated with an erythropoietin stimulating agent (ESA), wherein anemia is anemia associated with or secondary to dialysis-dependent chronic kidney disease (DD-CKD), and wherein the hemoglobin levels are increased to about at least 10 g/dL from a baseline hemoglobin level.
168 . A method of maintaining hemoglobin levels in a patient having anemia, comprising administering to the patient a dose of a compound that is {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid having the structure of Compound 1,
or a pharmaceutically acceptable salt, solvate, or hydrate thereof, wherein the dose comprises about 900 mg of Compound 1 three times weekly, wherein the patient was previously treated with an erythropoietin stimulating agent (ESA), wherein anemia is anemia associated with or secondary to dialysis-dependent chronic kidney disease (DD-CKD), and wherein the hemoglobin levels maintained at about 10.0-13.0 g/dL.
169 . A method of treating anemia, comprising administering to a patient having anemia a dose of a compound that is {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid having the structure of Compound 1,
or a pharmaceutically acceptable salt, solvate, or hydrate thereof, wherein the dose comprises about 1200 mg of Compound 1 three times weekly, wherein the patient was previously treated with an erythropoietin stimulating agent (ESA), wherein anemia is anemia associated with or secondary to dialysis-dependent chronic kidney disease (DD-CKD).
170 . A method of increasing hemoglobin levels in a patient having anemia, comprising administering to the patient a dose of a compound that is {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid having the structure of Compound 1,
or a pharmaceutically acceptable salt, solvate, or hydrate thereof, wherein the dose comprises about 1200 mg of Compound 1 three times weekly, wherein the patient was previously treated with an erythropoietin stimulating agent (ESA), wherein anemia is anemia associated with or secondary to dialysis-dependent chronic kidney disease (DD-CKD), and wherein the hemoglobin levels are increased to about at least 10 g/dL from a baseline hemoglobin level.
171 . A method of maintaining hemoglobin levels in a patient having anemia, comprising administering to the patient a dose of a compound that is {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid having the structure of Compound 1,
or a pharmaceutically acceptable salt, solvate, or hydrate thereof, wherein the dose comprises about 1200 mg of Compound 1 three times weekly, wherein the patient was previously treated with an erythropoietin stimulating agent (ESA), wherein anemia is anemia associated with or secondary to dialysis-dependent chronic kidney disease (DD-CKD), and wherein the hemoglobin levels maintained at about 10.0-13.0 g/dL.Cited by (0)
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